Kornimate/medical-research-clean huggingface dataset:
comparison of effectiveness and safety of three lock solutions for long-term central venous catheter for hemodialysis

Conditions: Chronic Kidney Disease

Summary: background: poor flow (pf) and catheter-related blood stream infections (crbsi) are highly prevalent among ckd 5d patients with long-term central venous catheters. heparin (h) catheter lock solutions are commonly used to maintain catheter patency, however pf and crbsi incidence remains high. the purpose of this study was to evaluate two lock solutions on reduction of pf and crbsi: one, a lock solution combining of the tetracycline antibiotic minocycline with the anticoagulant/chelation agent edta (m-edta) versus h; and other, trisodium citrate (c) versus h. m-edta and c were also evaluated as to their safety versus h. methods:as regards the pilot project, thirty ckd 5d patients on high-efficiency hemodialysis (blood flow rate = 350 ml/min) at the integrated centre of nephrology (guarulhos, brazil) were randomized 1:1:1 to receive m-edta, c or h locks for 15 weeks. lock solutions concentrations were m-edta 30 mg/ml/3 mg/ml, c 30% (c) and h 1,000 u/ml and both investigators and patients were blinded to treatment allocation. the primary end-point was a 10% reduction in hd blood flow rates (35ml). the frequency of crbsi was recorded. bleeding and lock solution-related adverse events were the primary safety end points. logistic regression was performed to evaluate differences in pf rates among the treatments (spss version 13.0, ibm, usa). based upon the pilot-study data, the clinical trials has being executed in order to verify whether the three lock solutions have the same performance or not.

methods: 75 ckd 5d patients on high-efficiency hemodialysis (blood flow rate = 350 ml/min) at the integrated centre of nephrology (guarulhos, brazil) will be randomized 1:1:1 to receive m-edta, c or h locks for 15 weeks. lock solutions concentrations are m-edta 30 mg/ml/3 mg/ml, c 30% (c) and h 1,000 u/ml and both investigators and patients are blinded to treatment allocation. the primary end-point is a 10% reduction in hd blood flow rates (35ml). the frequency of crbsi will be recorded. poor flow rate (event/1,000 catheter-day) and crbsi rate (event/1,000 catheter-day) will be calculated in each arm. bleeding and lock solution-related adverse events are also the primary safety end points and their rates (events/1,000 catheter-day) will be calculated. logistic regression will be performed to evaluate differences in pf, crbsi, bleeding and lock solution-related adverse events rates among the treatments (spss version 13.0, ibm, usa).

Eligibility criteria:
inclusion criteria: * male and female patients; * patients with subclavian long term central venous catheter; * patients on on high-efficiency hemodialysis (bfr= 350 ml; dialisate flow = 500 ml; 3 times; 4-hour sessions). exclusion criteria: * pregnant; patients on oral coagulants; patients aged less than 18 years; * patients aged more than 75 years

Keywords: renal dialysis
extension study of eculizumab in patients with transfusion dependent paroxysmal nocturnal hemoglobinuria (pnh)

Conditions: Paroxysmal Hemoglobinuria, Nocturnal

Summary: the purpose of this study is to evaluate the long-term safety of eculizumab in patients with transfusion dependent hemolytic pnh.

an open-label extension study to evaluate long-term safety of eculizumab in pnh patients who had completed the triumph (c04-001), shepherd (c04-002), and x03-001 studies.

Eligibility criteria:
inclusion criteria: * patients who have fully completed the triumph, shepherd, or x03-001 studies * triumph patients who have discontinued receiving investigational drug prior to the last visit of the study due to lack of efficacy or exacerbation of symptoms of pnh and have completed all monthly safety and efficacy procedures * patient must be willing and able to give written informed consent * patient must avoid conception during the trial exclusion criteria: * patients who have terminated early from the shepherd or x03-001 studies * patients who have terminated early from the triumph study due to an adverse event * female who is pregnant, breast feeding, or intending to conceive during the course of the study * any condition that could increase the patient's risk by participating in the study or could confound the outcome of the study

Keywords: transfusion dependent paroxysmal nocturnal hemoglobinuria hemolytic
research on hybrid operation technique in the treatment of complex brain arteriovenous malformations

Conditions: Cerebrovascular Disease; Arteriovenous Malformations; Complex; Primary

Summary: complex brain arteriovenous malformations (bavms) in ≥3 spetzler-martin grades have long been challenges among cerebrovascular diseases. none of the traditional methods, such as microsurgical operation, endovascular intervention, or stereotactic radiotherapy, can completely eliminate complex bavms without a risk of neural function deterioration. the multistaged hybrid operation solved part of the challenge but remained risky in the installment procedures and intervals. the one-staged hybrid operation was applied in the surgical treatment of cerebrovascular diseases and proved to be a potentially safe and effective method for curing complex bavms. however, lacking the support of high-level evidence, its advantages remain unclear. this study was proposed to validate the benefits and risks of one-staged hybrid operation in the treatment of complex bavms, as well as its indications, key technologies, and workflows.

the study is being conducted from jan 2016 to dec 2020 with 20 cooperation units. it consists of 2 sets. the registry set is designed as a prospective real-world registry. the trial set is designed as a prospective pragmatic clinical trial, specifically for the patients with perforating arterial feeders. the two sets share a common grouping: the traditional operation group and the one-staged hybrid operation group. the assignment is based on the clinical condition in the registry set and is randomized in the trial set. end points will be evaluated at scheduled time points. the safety and efficiency of one-staged hybrid operation in treating complex bavms will be validated.

Eligibility criteria:
inclusion criteria: 1. patients of all ages; 2. diagnosed with arteriovenous malformations (avms) in brain parenchyma (including cerebrum and cerebellum) by dsa, with/without dura arteriovenous fistula; 3. with any operative indications as follows: (1) with stable hematoma or history of hemorrhage due to bavms, and allowed selective operation; (2) with recurrent epilepsy seizure, having failed treatment with antiepileptic drugs (aeds); (3) with induced deterioration of neurological functions; 4. with spetzler-martin grades from i to iv; 5. who provide informed consent. exclusion criteria: 1. \>70 years old with no significant hemorrhagic risk of bavms; 2. with spetzler-martin grade ≥v; 3. accompanied by severe chronic disease, organ dysfunction, or malignant tumor that cannot tolerate the operation; 4. allergic to iodinated contrast agent; 5. unable to give informed consent.

Keywords: brain arteriovenous malformations one-staged hybrid operation
financial incentives to increase pediatric hiv testing

Conditions: HIV

Summary: the purpose of this study is to determine whether giving small financial incentives will motivate parents to test their children for hiv.

the study will be a randomized controlled trial (rct) with 5 arms with equal allocation to each arm: no incentive, or one of 4 different levels of financial incentive. we will randomize 800 parents with children of unknown status at hiv treatment clinics in western kenya.

Eligibility criteria:
inclusion criteria: * parent/caregiver receiving hiv care * parent/caregiver has one or more children \<13 years old * child is hiv exposed (parent/caregiver report or clinic confirmation) * caregiver reports child's hiv status is unknown exclusion criteria: * none * the investigators reserve the right to exclude any potential enrollee who is deemed to be at high personal risk, or whose children are at high personal risk, of interpersonal violence, by study participation .

Keywords: financial incentive pediatric hiv testing
initiation of noninvasive ventilation in als patients with chronic respiratory insufficiency

Conditions: Ventilation Therapy; ALS; Chronic Respiratory Failure

Summary: this research will study whether noninvasive ventilation (niv) used to treat chronic respiratory insufficiency in patients with amyotrophic lateral sclerosis (als) can be initiated as successfully in the outpatient setting as in the conventional inpatient setting, and what the costs of these alternative initiation methods are.


Eligibility criteria:
inclusion criteria: * als diagnosed by a neurology and * chronic respiratory insufficiency or significant respiratory muscle weakness caused by als exclusion criteria: * impaired cognition to give informed consent to participation * contraindication to niv therapy * another severe disease with a prognosis of less than one year * ventilation via an artificial airway, tracheostomy
hypoxia adaptation promotes cerebral functional connectivity with neuromuscular efficiency decrement

Conditions: Hypoxia; Altitude Sickness

Summary: the study utilized a trimodal setup comprising eeg, emg, and fnirs modules. participants wore a 64-channel dry eeg cap, while emg electrodes were placed on the right biceps brachii, the flexor digitorum profundus of the forearm, and the gastrocnemius muscle. fnirs probes were positioned on the forehead to monitor cerebral hemodynamic responses. the experimental paradigm included two tasks: motor execution (me) and motor imagery (mi). during me, participants performed 15 trials of actual movements. in mi, participants completed 60 trials of imagined movements. each trial involved a randomly presented stimulus-left-hand clenching, right-hand clenching, or bilateral heel raising-with each movement type occurring an equal number of times across the session.

this study employed a multimodal acquisition system comprising eeg, emg, and fnirs modules. participants were fitted with a 64-channel dry eeg cap for the measurement of cortical electrical activity. surface emg electrodes were attached to three muscle groups: the right biceps brachii, the flexor digitorum profundus of the forearm, and the gastrocnemius muscle, to record muscle activation signals. simultaneously, fnirs probes were positioned on the participants' foreheads to monitor cerebral hemodynamic responses. the experimental paradigm was divided into two tasks: motor execution (me) and motor imagery (mi). during the me task, participants performed 15 trials of actual movements, whereas the mi task involved 60 trials of imagined movements. each trial randomly presented one of three stimuli-left-hand clenching, right-hand clenching, or bilateral heel raising-with an equal distribution of the three movement types across the session. the order of stimuli was randomized to prevent prediction bias.

Eligibility criteria:
inclusion criteria: * people who can withstand altitude sickness exclusion criteria: * plateau native

Keywords: brain
cantata: cb-839 with cabozantinib vs. cabozantinib with placebo in patients with metastatic renal cell carcinoma

Conditions: Advanced Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma

Summary: tthe primary objective of this study is to compare blinded independent radiology committee (irc)-adjudicated progression free survival (pfs) of patients treated with cb-839 + cabozantinib (cb-cabo) versus placebo + cabozantinib (pbo-cabo) for advanced or metastatic clear-cell rcc (ccrcc).


Eligibility criteria:
inclusion criteria: 1. documented histological or cytological diagnosis of renal cell carcinoma with a clear-cell component 2. adult patients 3. karnofsky performance score (kps) ≥ 70% 4. measurable disease per response evaluation criteria in solid tumors version 1.1 (recist v1.1) 5. 1-2 lines of prior therapy for advanced or metastatic renal cell carcinoma (rcc) including one anti-angiogenic therapy (any vascular endothelial growth factor \[vegf\] pathway-targeted agent used either as monotherapy or as a component of a combination regimen) or the combination regimen of nivolumab + ipilimumab 6. adequate hepatic, renal, cardiac and hematologic function exclusion criteria: 1. prior treatment with cabozantinib (or other mesenchymal-epithelial transition \[met\] inhibitor) or cb-839 2. receipt of other anticancer therapy within 2-6 weeks, depending on the treatment 3. untreated or active brain metastases or central nervous system cancer, as defined per protocol 4. prior gastric surgery, small bowel resection, or other conditions that may impede adequate absorption of oral study drug 5. known active infection with human immunodeficiency virus (hiv), hepatitis b or c virus 6. inability to discontinue proton-pump-inhibitor use before randomization 7. patients who are pregnant or lactating

Keywords: tumor metabolism rcc glutaminase inhibitor cb-839 cantata tki tyrosine kinase inhibitor cabozantinib cabometyx cometriq glutaminase glutamine renal cell clear cell kidney cancer cmet met hgfr telaglenastat
a post-market clinical follow-up on safety and performance of the ophthalmic viscoelastic devices eyefill sc and eyefill mb

Conditions: Cataract

Summary: prospective, non-comparative, post market clinical follow up study to demonstrate safety and performance of eyefill® s.c. and eyefill® m.b. as viscoelastic devices for cataract surgery


Eligibility criteria:
inclusion criteria: * adult subjects scheduled for cataract surgery with im-plantation of a posterior chamber intraocular lens; * signed informed consent; * availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures exclusion criteria: * known hypersensitivity to sodium hyaluronate; * corneal endothelial cell density \<1500 cells/mm2; * corneal abnormalities; * cataract density of grade 4+; * previous intraocular or corneal surgery; * chronic or recurrent inflammatory eye diseases (e.g., iritis, scleritis, iridocyclitis, or rubeosis iridis); * clinically significant, uncontrolled glaucoma with expected negative impact on visual acuity outcomes; * ongoing systemic or ocular steroid therapy; * diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity loss to 20/30 or worse in one or both eyes; * active ocular or systemic infection (bacterial, viral, or fungal), including fever * subjects who may be expected to require a combined or other secondary surgical procedure * females of childbearing potential (those who are not surgically sterilized or not postmenopausal for at least 12 months) if they meet one of the following conditions: pregnant, lactating or unwilling to use effective birth control over the course of the study; * concurrent or previous (within 30 days) participation in another drug or device investigation.
a study of ak111 in subjects with moderate-to-severe plaque psoriasis

Conditions: Psoriasis

Summary: this is a phase ib clinical study of multiple dose escalation of ak111 in subjects with moderate-to-severe plaque psoriasis

this is a randomized, double-blind, placebo-controlled phase ib clinical study. this study aims to determine the safety, tolerance, pharmacokinetics(pk) and pharmacodynamics (pd) characteristics, immunogenicity and preliminary clinical efficacy of multiple dose escalation administration of ak111 in subjects with moderate-to-severe plaque psoriasis..

Eligibility criteria:
inclusion criteria: 1. moderate to severe plaque-type psoriasis diagnosed for at least 6 months; 2. subjects with moderate-to-severe plaque psoriasis at baseline, who were defined as follows: body surface area (bsa) ≥ 10%, pasi ≥ 12 and spga score ≥ 3; 3. subjects with a history of systemic therapy or phototherapy for psoriasis at least once before, or suitable to receive systemic therapy or phototherapy for psoriasis assessed by investigator; 4. women of childbearing age is not pregnant or lactating, and the subjects and their partners voluntarily take contraceptive measures considered effective by the investigator during the treatment period and at least 6 months after the last receipt of the study drug. exclusion criteria: 1. forms of psoriasis other than chronic plaque-type psoriasis; 2. history or evidence of active/latent tuberculosis; 3. positive results of confirmatory serology test for hepatitis b, hepatitis c,hiv or syphilis at screening; 4. history of serious infection within 2 months before screening; 5. history of malignancy of any organ system; 6. inadequate washout period for prior psoriatic therapy; 7. previous use of secukinumab, ixekizumab or any other drug that targets il-17 or il-17 receptor; 8. any medical conditions, in the opinion of the investigator, would place the subject at risk, interfere with study participation or study results interpretation.
the influence of dietary phosphorus education program on nutritional status and serum phosphate level among hemodialysis patient

Conditions: Hyperphosphatemia; Malnutrition

Summary: aim: dietary phosphorus education program can improve patients' knowledge, attitude and behavior of phosphorus restriction diet to reduce the risk of hyperphosphatemia and malnutrition of hemodialysis patients. inclusion criteria: the criteria of subjects are undergoing regular hemodialysis for longer than 3 months at baseline. subjects' age range is from 20 to 85 years old. their baseline serum albumin \ 5.0 mg/dl, are eligible for inclusion. subjects will be enrolled into this trial after signed informed consent. we expect to recruit 60 subjects. patients will be excluded if they had liver cirrhosis, malignant tumor, can't finish all education sessions and/or can't complete dietary records monthly. we will recruit a control group into this trial, they are eligible for inclusion but don't want to participant education sessions. intervention protocol: at baseline, the investigators collect demography and pre-test kap questionnaires among all subjects. if subjects were illiterate then investigator will conduct face-to-face interview and record their answers. dietary phosphorus education is a 6-month program and be implemented by dietitians and investigators, including education, nutritional counseling and dietary records monthly. the first month was intensive weekly education sessions, each 20 to 30 minutes. second and third month were monthly education sessions, each 20 to 30 minutes. there are total 6 sessions in this trial. the last 3 months will follow-up periods, will collect anthropometry data monthly, biochemistry measurements and 3-day dietary records among all subjects. if subjects were illiterate then investigator will conduct face-to-face interview or phone-interview to complete each dietary record. investigator collect post-test kap questionnaires, diet behavior questionnaires and satisfaction questionnaires from subjects in the end of the trial,. if subjects are illiterate then investigators interview subjects and record. this is a 6-months trial and retrospective study to collect anthropometry, biochemical measurements and 3-day dietary records from control subjects monthly.


Eligibility criteria:
inclusion criteria: * the criteria of subjects are undergoing regular hemodialysis for longer than 3 months at baseline. subjects' age range is from 20 to 85 years old. their baseline serum albumin \ 5.0 mg/dl, are eligible for inclusion. subjects will be enrolled into this trial after signed informed consent. we expect to recruit 60 subjects exclusion criteria: * patients will be excluded if they had liver cirrhosis, malignant tumor, can't finish all education sessions and/or can't complete dietary records monthly. * we will recruit a control group into this trial, they are eligible for inclusion but don't want to participant education sessions

Keywords: hyperphosphatemia or malnutrition
a study of the effectiveness and safety of topiramate compared with a standard therapy in patients newly diagnosed with epilepsy

Conditions: Epilepsy; Seizures

Summary: the purpose of this study is to compare the effectiveness and safety of topiramate to standard antiepileptic drugs in children and adults with newly diagnosed epilepsy.

topiramate is a drug that is currently widely used for the treatment of seizures in adults and pediatric patients (2 to 16 years of age). this is a randomized, double-blind, parallel-group study to evaluate the effectiveness and safety of two dosages of topiramate (100 or 200mg per day) compared with standard antiepileptic drugs (carbamazepine or valproate) in patients with newly diagnosed epilepsy. the study is composed of three phases: baseline (up to 7 days), double-blind treatment, and a blinded extension. the double-blind phase is divided into two periods: titration, in which the dose of drug is gradually increased (approximately 35 days), and stabilization (of variable duration, with regular scheduled visits up to 92 days and then every 3 months thereafter). the dose of study drug remains constant during the stabilization period. in the blinded extension, patients completing the double blind phase are given the opportunity to take the other study medication in a blinded fashion (patient unaware of identity of the drug). this phase continues until the patient leaves the study or the data base for the double blind phase is finalized. the primary assessment of effectiveness is the time to first seizure from day 15 of the study. safety assessments include the frequency of adverse events during the study, results of clinical laboratory tests (hematology and biochemistry), measurements of vital signs and body weight, and physical examination findings. the study hypothesis is that the 200mg dose of topiramate is superior to the 100mg dose in delaying the time to first seizure and is well-tolerated. oral topiramate (25milligram \[mg\] or 50mg capsules or tablets),starting at 25mg/day (week 1),increasing to 100mg or 200mg/day (week 5).increasing carbamazepine to 600mg/day or valproate to 1250mg/day (week 5).maximum dosages continue for a variable time and then taper over 4 weeks to starting dose.

Eligibility criteria:
inclusion criteria: * body weight of at least 30 kilograms * new epilepsy diagnosis and at least one unprovoked seizure within 3 months before study entry * no history of antiepileptic drug use or taking a single antiepileptic drug for no longer than 6 weeks * females must be sexually abstinent, surgically sterile, or using adequate birth control measures, and have a negative pregnancy test before study entry exclusion criteria: * patients who do not have epilepsy * have progressive or degenerative disorders (for example, certain hereditary conditions) * have a significant history (within last 2 years) of unstable medical diseases (heart, kidney, hormone, or liver diseases) * have mental retardation or other condition that could make interpretation of the study results difficult * alcohol or drug abuse within the previous year

Keywords: epilepsy seizures topiramate prophylaxis antiepileptic